The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Fielder Xt-a, Asahi Fielder Xt-r.
| Device ID | K153106 |
| 510k Number | K153106 |
| Device Name: | ASAHI Fielder XT-A, ASAHI Fielder XT-R |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC CO., LTD. 1703 WAKITA-CHO, MORIYAMA-KU Nagoya, JP 463-0024 |
| Contact | Yoshihiko Fukui |
| Correspondent | Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-27 |
| Decision Date | 2016-06-21 |
| Summary: | summary |